WASHINGTON – The US Food and Drug Administration (FDA) on Monday (Aug 23) gave approval to Pfizer’s Comirnaty vaccine for the prevention of Covid-19 in individuals aged 16 and above.
“Today, FDA approved the first Covid-19 vaccine for the prevention of #COVID19 disease in individuals 16 years of age and older,” the agency wrote in a post on Twitter.
“The vaccine also continues to be available under emergency use authorisation (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals,” it added in a separate tweet.
Acting FDA Commissioner Janet Woodcock called the FDA’s approval of the vaccine a milestone in the battle against Covid-19.
In a tweet, Dr Woodcock wrote: “As the first FDA-approved Covid-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”
“While millions of people have already safely received Covid-19 vaccines, we recognise that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.”
“Today’s milestone puts us one step closer to altering the course of this pandemic in the US,” she added.